Monitoring system and method

ABSTRACT

A monitoring system comprises:a first device configured tocapture an image of a medicament dosage indicated by a medicament dispensing device by an image capturing component of the first device;display the image of the medicament dosage on a display of the first device; andtransmit data representing the image of the medicament dosage to a second device; and computer code that when executed by a second device causes the second device to:receive the data representing the image of the medicament dosage sent by the first device;perform optical character recognition on the data of the medicament dosage thereby to identify the dosage indicated by the medicament dispensing device; andmake a non-transient record of dosage information based at least in part on the identified medicament dosage.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.17/138,273, filed Dec. 30, 2020, which is a continuation of U.S. patentapplication Ser. No. 15/320,156, filed Dec. 19, 2016, which is a U.S.national stage application under 35 USC § 371 of InternationalApplication No. PCT/EP2015/064348, filed on Jun. 25, 2015, which claimspriority to European Patent Application No. 14174717.0 filed on Jun. 27,2014, the entire contents of which are incorporated herein by reference.

FIELD

The present disclosure relates to a monitoring system and to a method ofoperating a monitoring system.

BACKGROUND

A variety of diseases exist that require regular treatment by injectionof a medicament. Such injections can be performed by using injectiondevices, which are applied either by medical personnel or by patientsthemselves. As an example, type-1 and type-2 diabetes can be treated bypatients themselves by injection of insulin doses, for example once orseveral times per day. For instance, a pre-filled disposable insulin pencan be used as an injection device. Alternatively, a re-usable pen maybe used. A re-usable pen allows replacement of an empty medicamentcartridge by a new one. Either pen may come with a set of one-wayneedles that are replaced before each use. The insulin dose to beinjected can then for instance be manually selected at the insulin penby turning a dosage dial and observing the actual dose from a dosagewindow of the insulin pen. The dose is then injected by inserting theneedle into a suited skin portion and pressing an injection button ofthe insulin pen. To be able to monitor insulin injection, for instanceto prevent false handling of the insulin pen or to keep track of thedoses already applied or remaining, it is desirable to measureinformation related to a condition and/or use of the injection device,such as for instance information on the injected insulin type and dose.

For a good treatment of insulin it is necessary to keep a diary todocument the day, time and amount of insulin dose. Some patients forgetto write the information down or cannot remember when and how muchinsulin they have injected. Therefore, there is a strong need forfurther support or automation of this process to make it easier for thepatient to keep track of his/her diary.

SUMMARY

A first aspect of the disclosure provides a monitoring systemcomprising,

a first device (2) configured to

-   -   capture an image of a medicament dosage indicated by a        medicament dispensing device by an image capturing component of        the first device;    -   display the image of the medicament dosage on a display (21) of        the first device; and    -   transmit data representing the image of the medicament dosage to        a second device; and computer code that when executed by a        second device causes the second device (100) to:    -   receive the data representing the image of the medicament dosage        sent by the first device (2);    -   perform optical character recognition on the data of the        medicament dosage thereby to identify the dosage indicated by        the medicament dispensing device; and    -   make a non-transient record of dosage information based at least        in part on the identified medicament dosage.

A system so constructed can provide the advantages of a supplementdevice that performs OCR and determines delivered dose of medicament butwithout requiring the hardware needed to perform OCR in the supplementaldevice. This can reduce the hardware cost of the supplemental device.Moreover, the use of an external device as the second device allows thepossibility of a more accurate and reliable OCR process than would beobtainable from OCR recourses that could practically be included in thesupplemental device. This is especially the case when the second devicecompromises a mobile phone such as a smart phone.

The first device may be configured to transmit the data representing theimage of the medicament dosage to the second device in response to auser input on the first device or on the second device. This can allowtransfer of the data to the second device when there is a change in theuse of the dispensing device (e.g. from dialling to injecting or frominjecting to injected) or by user input but without utilisingcommunication resources at other times.

The first device may be configured to transmit the data representing theimage of the medicament dosage to the second device periodically orcontinually. This can allow the medicament dosage to be identified anddisplayed as the user is e.g. dialling and/or injecting medicament,although at the cost of increased communication resource utilisation.

The first device may be configured to capture images of a medicamentdosage indicated by the medicament dispensing device and display theimages of the medicament dosage periodically or continually. This canallow the user to determine the dialled dose easily and is particularlyuseful during the dialling and injecting phases of use of the dispensingdevice.

The first device may be configured to capture images of a medicamentdosage indicated by the medicament dispensing device and display theimage of the medicament dosage plural times a second. This can allow theuser to determine the dialled dose particularly easily and can allow theuser to dial the correct dose and dispense the dose more quickly andefficiently than with other arrangements, and may provide an experiencesimilar to the use of a dispensing device that is not fitted with anexternal device with a recording facility.

The first device may be configured to cause a first display after afirst user input on the first device and to cause a second display aftera second input on the first device. This can allow a user to determinefrom the display on the first device whether or not a dose set input,the dwell time a dose delivered input and/or no input has been recordedby the first device.

The non-transient record of dosage information may include a time and/ordate information taken from a clock of the first or second device.

The second device may be a mobile telephone.

The computer code may comprise a discreet software application. Thesoftware application may be downloadable, for instance from anapplication market place or store.

The computer code when executed by the second device may cause thesecond device to display the identified medicament dosage.

A second aspect of the disclosure provides a method of operating amonitoring system, the method comprising,

a first device (2):

-   -   capturing an image of a medicament dosage indicated by a        medicament dispensing device by an image capturing component of        the first device;    -   displaying the image of the medicament dosage on a display (21)        of the first device; and    -   transmitting data representing the image of the medicament        dosage to a second device; and        a second device (100):    -   receiving the data representing the image of the medicament        dosage sent by the first device (2);    -   performing optical character recognition on the data of the        medicament dosage thereby to identify the dosage indicated by        the medicament dispensing device; and    -   making a non-transient record of dosage information based at        least in part on the identified medicament dosage.

BRIEF DESCRIPTION OF THE FIGURES

In the Figures:

FIG. 1a is an exploded view of a drug delivery device;

FIG. 1b shows a perspective view of some detail of the drug deliverydevice of FIG. 1 a;

FIG. 2a is an isometric projection of a sensor device or supplementarydevice according to embodiments of the present disclosure;

FIG. 2b is an isometric projection of another sensor device orsupplementary device according to embodiments of the present disclosure;

FIG. 2c is an isometric projection of a still further sensor device orsupplementary device according to embodiments of the present disclosure;

FIG. 3 is a schematic view of a sensor device as in FIGS. 2 a, b, cattached to a drug delivery device and showing internal components ofthe sensor device;

FIG. 4 shows the FIG. 1a injection device 1 fitted with a FIG. 2 a, b,c, sensor device and wirelessly communicating with a mobile terminal;

FIG. 5 is a schematic view of the mobile terminal of FIG. 4 and showinginternal components of the mobile terminal 100;

FIG. 6 is a flow chart showing operation of the FIGS. 2 a, b, c sensordevice or supplementary device according to embodiments of thedisclosure; and

FIG. 7 is a flow chart showing operation of the FIG. 4 mobile terminalaccording to embodiments of the disclosure.

DETAILED DESCRIPTION OF SOME EMBODIMENTS OF THE DISCLOSURE

In the following, embodiments of the present disclosure will bedescribed with reference to an insulin injection device. The presentdisclosure is however not limited to such application and may equallywell be deployed with injection devices that eject other medicaments, orwith other types of medicament administration devices.

FIG. 1a is an exploded view of an injection device 1, which may forinstance represent Sanofi's Solostar™ insulin injection pen.

The injection device 1 of FIG. 1a is a pre-filled, disposable injectionpen that comprises a housing 10 and contains an insulin container 14, towhich a needle 15 can be affixed. The needle is protected by an innerneedle cap 16 and an outer needle cap 17, which in turn can be coveredby a cap 18. An insulin dose to be ejected from injection device 1 canbe selected by turning the dosage dial 12, and the selected dose is thendisplayed via dosage window 13, for instance in multiples of so-calledInternational Units (IU), wherein one IU is the biological equivalent ofabout 45.5 micrograms of pure crystalline insulin ( 1/22 mg). An exampleof a selected dose displayed in dosage window 13 may for instance be 30IUs, as shown in FIG. 1a . It should be noted that the selected dose mayequally well be displayed differently. A label (not shown) is providedon the housing 10. The label includes information about the medicamentincluded within the injection device 1, including informationidentifying the medicament.

Turning the dosage dial 12 causes a mechanical clicker to provide hapticand acoustic feedback to a user. The numbers displayed in dosage window13 are present on a sleeve by printing and the sleeve is contained inhousing 10 and mechanically interacts with a piston in insulin container14. When needle 15 is stuck into a skin portion of a patient, and theninjection button 11 is pushed, the insulin dose displayed in displaywindow 13 will be ejected from injection device 1. When the needle 15 ofinjection device 1 remains for a certain time in the skin portion afterthe injection button 11 is pushed, a high percentage of the dose isactually injected into the patient's body. Ejection of the insulin dosealso causes a mechanical click sound, which is however different fromthe sounds produced when using dosage dial 12.

Injection device 1 may be used for several injection processes untileither insulin container 14 is empty or the expiration date of injectiondevice 1 (e.g. 28 days after the first use) is reached.

Furthermore, before using injection device 1 for the first time, it maybe necessary to perform a so-called “prime shot” to remove air frominsulin container 14 and needle 15, for instance by selecting two unitsof insulin and pressing injection button 11 while holding injectiondevice 1 with the needle 15 upwards.

For simplicity of presentation, in the following, it will be exemplarilyassumed that the ejected doses substantially correspond to the injecteddoses, so that, for instance when making a proposal for a dose to beinjected next, this dose equals the dose that has to ejected by theinjection device 1. Nevertheless, differences (e.g. losses) between theejected doses and the injected doses may of course be taken intoaccount.

FIG. 1b is a close-up of the end of the injection device 1. This Figureshows a locating rib 70 that is located between the dosage window 13 andthe dosage dial 12.

FIG. 2a shows an embodiment of a supplementary device 2 to be releasablyattached to injection device 1 of FIG. 1a . Supplementary device 2comprises a housing 20 with a mating unit configured to embrace thehousing 10 of injection device 1 of FIG. 1a , so that supplementarydevice 2 sits tightly on housing 10 of injection device 1, but isnevertheless removable from injection device 1, for instance wheninjection device 1 is empty and needs to be replaced. FIG. 2a isschematic, and details of the physical arrangement are described belowwith reference to FIGS. 2b and 2 c.

Supplementary device 2 contains optical sensors for gatheringinformation from injection device 1. As described below, a selected dose(also known as a dialled dose) is displayed via LCD display 21 ofsupplementary device 2. The dosage window 13 of injection device 1 isobstructed by supplementary device 2 when attached to injection device1.

Supplementary device 2 further comprises at least one user inputtransducer or switch 22, illustrated schematically as a button typeswitch. These input transducers 22 allow a user to turn on/offsupplementary device 2, to trigger actions (for instance to causeestablishment of a connection to or a pairing with another device,and/or to trigger transmission of information from supplementary device2 to another device), or to confirm something.

FIG. 2b is a schematic illustration of a second embodiment of asupplementary device 2 to be releasably attached to injection device 1of FIG. 1a . Supplementary device 2 comprises a housing 20 with a matingunit configured to embrace the housing 10 of injection device 1 of FIG.1a , so that supplementary device 2 sits tightly on housing 10 ofinjection device 1, but is nevertheless removable from injection device1.

Information is displayed via LCD display 21 of supplementary device 2.The dosage window 13 of injection device 1 is obstructed bysupplementary device 2 when attached to injection device 1.

Supplementary device 2 further comprises three user input transducers,buttons or switches. A first button 22 is a power on/off button, viawhich the supplementary device 2 may for instance be turned on and off.A second button 33 is a communications button. A third button 34 is aconfirm or OK button. The buttons 22, 33, 34 may take any suitable form.These input buttons 22, 33, 34 allow a user to turn on/off supplementarydevice 2, to trigger actions (for instance to cause establishment of aconnection to or a pairing with another device, to trigger transmissionof information from supplementary device 2 to another device), toconfirm something, and/or to display information on the LCD display 21.

FIG. 2c is a schematic illustration of a third embodiment of asupplementary device 2 to be releasably attached to injection device 1of FIG. 1a . Supplementary device 2 comprises a housing 20 with a matingunit configured to embrace the housing 10 of injection device 1 of FIG.1a , so that supplementary device 2 sits tightly on housing 10 ofinjection device 1, but is nevertheless removable from injection device1.

Information is displayed via LCD display 21 of the supplementary device2. The dosage window 13 of injection device 1 is obstructed bysupplementary device 2 when attached to injection device 1.

Supplementary device 2 further comprises a touch-sensitive inputtransducer 35. It also comprises a single user input button or switch22. The button 22 is a power on/off button, via which the supplementarydevice 2 may for instance be turned on and off. The touch sensitiveinput transducer 35 can be used to trigger actions (for instance tocause establishment of a connection to or a pairing with another device,and/or to trigger transmission of image data information fromsupplementary device 2 to the mobile device 100. This multi-functiontouch-sensitive input transducer 35 removes the need for thecommunications button 33 or a confirm button 34 and simplifies theconfiguration of the supplementary device 2. Such a multi-functiontransducer 35 may be mechanical instead of being touch-sensitive.

The mobile device 100 may display the dose dialled into the injectiondevice 1. This can allow the user to check the dialled dose calculatedby the mobile device 100 against the dose displayed on the LCD display21 of the supplementary device 2. The mobile device 100, through themedicament administration monitoring application 110, may allow the userto vary the dialled dose from that calculated by the optical characterrecognition process. This can allow more accurate recordal of medicamentadministration. The mobile device 100 may alternatively or additionallyrequire the user to confirm the displayed dose, or allow the user toconfirm that the displayed dose is the dialled dose.

FIG. 3 shows a schematic view of the supplementary device 2 of FIG. 2bor 2 c in a state where it is attached to injection device 1 of FIG. 1a.

With the housing 20 of supplementary device 2, a plurality of componentsis contained. These are controlled by a processor 24, which may forinstance be a microprocessor, a Digital Signal Processor (DSP),Application Specific Integrated Circuit (ASIC), Field Programmable GateArray (FPGA) or the like. Processor 24 executes program code (e.g.software or firmware) stored in a program memory 240, and uses a mainmemory 241, for instance to store intermediate results. Program memory240 may for instance be a Read-Only Memory (ROM) or Flash memory, andmain memory may for instance be a Random Access Memory (RAM).

In embodiments such as those shown in FIG. 2b , processor 24 interactswith the first button 22, via which supplementary device 2 may forinstance be turned on and off. The second button 33 may be used totrigger establishment of a connection to another device, or to trigger atransmission of information to another device. The third button 34 canbe used to acknowledge information presented to a user of supplementarydevice 2.

In embodiments such as those shown in FIG. 2c , two of the buttons 33,34 may be omitted. Instead, one or more capacitive sensors or othertouch sensors are provided.

Processor 24 controls a display 21, which is presently embodied as aLiquid Crystal Display (LCD). LCD display 21 is used to displayinformation to a user of supplementary device 2, for instance on presentsettings of injection device 1, or on a next injection to be given. LCDdisplay 21 may also be embodied as a touch-screen display, for instanceto receive user input.

Processor 24 also controls an image capture device 25 that is configuredto capture images of the dosage window 13, in which a currently selected(dialled) dose is displayed (by way of numbers, characters, symbols orglyphs present on the sleeve 19 contained in injection device 1, whichnumbers are visible through the dosage window 13). The image capturedevice 25 may be a camera of any suitable type.

Processor 24 also controls one or more light-sources such as lightemitting diodes (LEDs) 29 to illuminate the scene that is visiblethrough the dosage window 13, in which a currently selected dose isdisplayed. A diffuser may be used in front of the light-sources, forinstance a diffuser made from a piece of acrylic glass or polycarbonate.Furthermore, the optical sensor may comprise a lens system, for instanceincluding two aspheric lenses. The magnification ratio (image size toobject size ratio) may be smaller than 1. The magnification ratio may bein the range of 0.05 to 0.5.

Processor 24 controls a wireless unit 28, which is configured totransmit and/or receive information to/from another device in a wirelessfashion. Such transmission may for instance be based on radiotransmission or optical transmission. In some embodiments, the wirelessunit 28 is a Bluetooth or Bluetooth Low Energy transceiver.Alternatively, wireless unit 28 may be substituted or complemented by awired unit configured to transmit and/or receive information to/fromanother device in a wire-bound fashion, for instance via a cable orfibre connection.

The supplementary device 2 of FIG. 3 is thus capable of capturinginformation related to a condition and/or use of injection device 1.This information is displayed on the display 21 for use by the user ofthe device and some of the information is transmitted wirelessly toanother device.

FIG. 4 shows the supplementary device and injection device 1 being usedin conjunction with a mobile device 100 such as a smartphone. The mobiledevice 100 is programmed in a suitable way, for instance by beingprovided with a suitable software application 110.

In brief, the system of the supplementary device 2 and the mobile device100 function to display and record medicament dosage when the injectiondevice 1 is used. The supplementary device 2 communicates with themobile device 100 using a communication interface 28 e.g. Bluetooth. Theuser interacts primarily with the supplementary device 2. The mobiledevice 100 serves primarily to provide information to the user and torecord the user's injection history. The supplementary device 2transmits data representing an image captured by the camera 25 of thescene through the dosage window 13 to the mobile device 100 via apredefined communication channel 111 (see FIG. 4). The mobile device 100performs Optical Character Recognition (OCR) processing to identify theselected medicament dosage from the image data received from thesupplementary device 2. The mobile device 100 may identify the selecteddose before and after dispensing, calculate the administered dosage,display the administered dose and makes a record of the administereddosage information. A time stamp may be added to the dosage information.A more detailed explanation of how the system is configured andfunctions is described below.

The camera image taken is stored in the memory 241 of the supplementarydevice 2 together with a time stamp and information about the drug type.

Some of the internal components of the mobile device 100 are shown inFIG. 5. The mobile device 100 includes a processor 102. The processor102 controls operation of the other hardware components of the mobiledevice 100. The processor 102 and other hardware components may beconnected via a system bus (not shown). Each hardware component may beconnected to the system bus either directly or via an interface.

The mobile device 100 comprises a memory 104, i.e. a working or volatilememory, such as Random Access Memory (RAM), and a non-volatile memory.The non-volatile memory stores an operating system 108 and a medicamentadministration monitoring function 110, which advantageously is adistinct application, as well as storing data files and associatedmetadata. The medicament administration monitoring application 110 maybe provided in the mobile device 100 on manufacture or it may be downloaded into the mobile device 100 by a user, for instance from anapplication market place or application store.

The mobile device 100 comprises a display 112 (for instance an LCD, TFT(thin film transistor), OLED (organic light emitting diode), ePaper).The display may be a touch sensitive display having a display part 113and a tactile interface part 114. The mobile device 100 also includes acommunications interface 116, such as a Bluetooth interface. The mobiledevice 100 also houses a battery 118 to power the mobile device 100 by apower supply 119.

The processor 102 is configured to send and receive signals to and fromthe other components in order to control operation of the othercomponents. For example, the processor 102 controls the display ofcontent on display 112 and receives signals as a result of user inputsfrom tactile interface 114. The display 112 may be a resistive touchscreen or capacitive touch screen of any kind. The display mayalternatively not be a touch screen. For instance it may be a liquidcrystal display (LCD).

The mobile device 100 may be a mobile phone, PDA or tablet computer ofany kind, or it may be a BGM (blood glucose meter) device. Otherstandard or optional components of the mobile device 100, such astransceivers and cameras, are omitted. The processor 102 may be anintegrated circuit of any kind. The processor 102 may access RAM inorder to process data and may control the storage of data in memory 104.Memory 104 may be a non-volatile memory of any kind such as a Read OnlyMemory (ROM), a flash memory and a magnetic drive memory. The RAM may bea RAM of any type, for example Static RAM (SRAM), Dynamic RAM (DRAM) ora Flash memory.

The processor 102 operates under control of the operating system 108.The operating system 108 may comprise code relating to hardware such asthe display 112 and communications interface 116, as well as the basicoperation of the mobile device 100. The operating system 108 may alsocause activation of other software modules stored in the memory 104,such as the medicament administration monitoring function 110.

FIG. 6 and FIG. 7 are flow charts illustrating operation of thesupplementary device 2 and the mobile device 1 a respectively. The flowcharts illustrate how the supplementary device 2 and the mobile device100 interact and operate as a system when the injection device 1 isbeing utilised. The steps of FIG. 6 are performed by the processor 24 ofthe supplementary device 2 under control of the software stored in thememory 240.

In FIG. 6, the operation 600 starts for instance when the supplementarydevice 2 is turned on or is otherwise activated at 601. In a step 602,the processor 24 controls the camera 25 to capture an image of thecurrent dosage displayed on the number sleeve of the injection device 1,as is visible through the dosage window 13 of the injection device 1.This image is then caused to be displayed on the LCD display 21 of thesupplementary device 2 in a step 603. The image is processed to somedegree before display. In particular, the image may be resized so as tofit the LCD display 21. In the case of the camera having more pixelsthan the LCD display 21, resizing involves downscaling the image.Downscaling may comprise for instance selecting only some pixels of thecaptured image for display (and not displaying others), or averaginggroups of pixels. The image advantageously is displayed in greyscale.This avoids the need for the supplementary device to perform processingof the image to detect boundaries of characters etc. It also reduces thepossibility that the displayed image is significantly different from thescene in front of the camera 25. Alternatively, the image may bedisplayed in black and white (without greyscale), or colour.

In a step 604, it is checked whether a user input, indicating that arequired dosage has been set, has been provided for instance by a buttonpress on the supplementary device 2. If no button press is detected, theoperation proceeds to step 614, where it is determined if the powerbutton 22 has been pressed. On a negative determination, the operationproceeds to step 615, where it is determined if there is a time outcondition. The time out condition occurs when a timer that is reset andstarted when the supplementary device 2 powers on or when it is detectedthat the power button 22 has been pressed has expired. A suitable valuefor the timer may be 60 or 120 seconds. On a negative determination fromstep 615, the operation returns to step 602, where a next image iscaptured and then displayed at step 603.

On a positive determination from step 614 or 615, indicating that thetime out condition has occurred or the user has pressed the power button22, the supplementary device 2 powers off and the operation ends at step616. This helps to minimise power consumption of the supplementarydevice but without impinging on operation when the user is interactingwith the supplementary device 2 or the injection device 1.

The sequence from step 604 to step 614 to step 615 then to step 602causes the supplementary device 2 to remain capturing images anddisplaying them until either the power button 22 is pressed or the timeout condition occurs or until it is determined at step 604 that theconfirm or OK button 34 to set dose has been pressed. This loop allowsthe user to set the required dosage by turning the dosage dial 12 on theinjection device 1 and reading the image containing the current dosageinformation displayed on the LCD display 21. Therein, if the power offbutton 22 press is detected in step 614, the processor 24 turns thesupplementary device 2 off. If no power off button 22 press is detectedbut a timeout is reached in step 615, the processor 24 turns thesupplementary device 2 off.

When the processor 24 detects a confirm or OK button 34 press by theuser to confirm that a required dosage has been set in 604, at step 605a dose set condition is indicated on the display 21 by the processor 24.The processor 24 then controls the wireless unit 28 to transmit datarepresenting the image of the currently dialled dose to the mobiledevice 100 in step 606 for further processing. Advantageously, the datarepresenting the image that is transmitted is the whole image, relatingto all of the pixels and including a greyscale value for each pixel.Alternatively, there may be some pre-processing of the image beforetransmission. However, no optical character recognition is performed onthe image before transmission. The transmitted data represents an imageand is not indicative of a set dose other than the data being an imageof the dose dialled into the injection device 1 at the time the imagewas captured. The image may be compressed in a lossy or lossless mannerbefore transmission time and communication resave initialisation.

In a step 607, the processor 24 controls the LCD display 21 to display“Administering”. At this stage, the user may be administering(delivering) the dose dialled into the injection device 1 before theconfirm or OK button 34 to set dose was detected to be pressed at step604.

Steps 605 and 607 may be performed in the other order, or they may beperformed in parallel with one another.

In a step 608, the processor 24 controls the camera to capture an imagein front of the camera, which indicates the current dosage as visible inthe dosage window 13. This image is then displayed on the LCD display 21of the device in a step 609. Steps 608 and 609 are the same as steps 602and 603 as described above.

When the injection process is complete, the user is expected to press aconfirm or OK button 34 on the supplementary device 2 to indicate “Enddose” to the processor 24 at step 610. If the processor 24 at step 610detects a confirm or OK button 34 press that indicates the “End dose”,it controls the LCD display 21 to display “Complete” in a step 611. In astep 612, the current image is transmitted to the mobile device 100.Steps 612 and 611 may be performed in the other order, or they may beperformed in parallel.

Next it is determined at step 613 whether the power button 22 has beenpressed. If it is detected at step 613 that the power button 22 has beenpressed, the supplementary device 2 then turns off at step 620. If not,it returns to step 602, where the image in front of the camera 25 iscaptured before being displayed at step 603. This repeats until the timeout condition occurs or the power button 22 is pressed.

If no confirm or OK button 34 press is detected in step 610 theoperation proceeds to step 617, where it is determined if the powerbutton 22 has been pressed. On a negative determination, the operationproceeds to step 618, where it is determined if there is a time outcondition. The time out condition occurs when a timer that is reset andstarted when the supplementary device 2 powers on or when it is detectedthat the power button 22 has been pressed has expired. A suitable valuefor the timer may be 60 or 120 seconds. On a negative determination fromstep 618, the operation returns to step 608, where a next image iscaptured and then displayed at step 609.

On a positive determination from step 617 or 618, indicating that userhas pressed the power button 22 or the time out condition has occurred,the supplementary device 2 transmits the current image to the mobiledevice 100 and then powers off ending the operation at step 620. Thishelps to minimise power consumption of the supplementary device 2 butwithout impinging on operation when the user is interacting with thesupplementary device 2. Further, transmitting the current image to themobile device 100 at this stage i.e. before power off also ensures thatthe final dosage information is recorded on the mobile device 100. Thisscenario could arise as a result of the user forgetting to press theconfirm or OK button 34 at step 610 to indicate “End dose” to theprocessor 24 after the injection process is complete.

FIG. 7 is a flowchart of the method steps that are performed by themobile device 100 in conjunction with the method steps performed by thesupplementary device 2 in FIG. 6. In FIG. 7, the flowchart 700 starts atstep 701 for instance when the supplementary device 2 is turned on or isotherwise activated. Following transmission of the image data in step606 of FIG. 6, in step 702 the mobile device 100 receives the imagedata. This constitutes image data containing information of themedicament dosage set by the user and sent from the supplementary device2. In step 703, the mobile device 100 performs optical characterrecognition processing on the received data. This can be performed inany suitable way. The optical character recognition involves processingthe image of the number sleeve that is in the scene in front of thecamera 25 of the supplementary device 2 to identify the dose that isdialled into the supplementary device 2. The result is a number thatrepresents the dialled dose, for instance in IU. The number may beprovided by the optical character recognition process as an integer orit may be between integer numbers if the optical character recognitionprocess is suitably configured.

After the dialled dose has been determined through the optical characterrecognition process, the mobile device 100 is controlled by themedicament administration monitoring application to display theidentified dialled or set dosage information to the user on the display113 at step 704. The dialled dosage is displayed to the user on thedisplay 113 along with an indication that it is the dialled dose, notthe dispensed dose, that is being displayed. The indication may take anysuitable form. For example, the indication may comprise the word“selected”, “dialled”, or “set”, or any other text form suitable and/orcommon to indicate to a user that it is the dialled dose, not thedispensed dose that is being displayed. The text format comprises alsoany translation into a language that is being set in the device. Theindication may comprise an image, such as a pictogram suitable and/orcommon to indicate to a user that it is the dialled dose, not thedispensed dose that is being displayed. The image indication may beprovided as alternative or in combination with a text-based indication.

At step 705, the mobile device 100 determines whether a delivered doseimage has been received from the supplemental device 2. If no delivereddose image data has been received, the mobile device 100 returns to step704, where the dialled dose is again displayed. This repeats until adelivered dose image is received from the supplemental device 2.

If the mobile device 100 determines at step 705 that it has receiveddelivered dose image data containing information of the final dose afterthe injection has been administered, it performs optical recognitionprocessing on the delivered dose image data at step 706, in any suitableway. This results in a number that indicates the dialled dose afterinjection/delivery. The mobile device 100 then calculates at step 707the delivered dose using the dialled and final dose information receivedfrom the supplementary device 2, in particular by subtracting the doseshown after delivery from the dose shown before delivery. Alternatively,if it is detected or assumed that the final dose is zero, this can beomitted. The calculated delivered dose information is displayed to theuser on the mobile device 100 by the medicament administrationmonitoring application 110 in a step 708. The delivered dose informationis then stored in the memory 104 of the mobile device 100 at step 709before the operation ends at step 710.

The storage of the dose information at step 709 constitutes a record ofthe medicament administration. The record includes the time or time anddate of administration, taken from the internal clock of the mobiledevice 100, the dose delivered and optionally other information providedby the user such as a blood glucose measurement taken before themedicament delivery, the type of medicament etc. This allows a completerecord of the medicament intake of the user to be recorded by the mobiledevice 100 without requiring the user to enter the dialled,post-delivered or delivered dose.

Operation of the system will now be described from the usersperspective.

The user begins by turning on the supplementary device 2 (which requiresone press of the power button 22) and opening or initiating themedicament administration monitoring application 110 on the mobiledevice 100. Next, a communications channel 111 between the supplementarydevice 2 and the mobile device 100 is established. This can be achievedby the user pressing the communications button 33 on the supplementarydevice 2. In this case, the user may need to interact with themedicament administration monitoring application 110 on the mobiledevice 100 to allow the connection to be established, or connection maybe automatic if the devices have been suitably configured, for instancethrough Bluetooth pairing. Alternatively, a communications link betweenthe supplementary device 2 and the mobile device 100 may be establishedwithout requiring any user input, for instance in response to thesupplementary device 2 being powered on. The receipt by the mobiledevice 100 of a signal from the supplemental device 2 may cause themobile device 100 to launch the medicament administration monitoringapplication 110 on the mobile device 100.

When turned on, the current dosage on the injection device 1 isdisplayed to the user on the supplementary device 2 LCD display 21. Theuser can now set the required medicament dosage by turning the dosagedial 12 on the injection device 1 while reading the current dosagereading on the LCD display 21.

When the required medicament dosage is set, the user presses the confirmor OK button 34 on the supplementary device 2. At this time, thesupplementary device 2 is displaying the medicament dose on the LCDdisplay 21. The medicament administration monitoring application 110 onthe mobile device 100 then displays the dosage set by the user on themobile device 100 display. The user is now able to double-check that thecorrect dose has been recognised by the mobile device 100. However, theuser does not need to check the mobile device 100 at this stage.

After a short time, the display of the LCD display 21 on thesupplementary device 2 then changes to indicate that the dose has beenset. Before or after this change in display, the user can start toinject the medicament. As the medicament is administered, the dosagereading on the LCD display 21 changes as the dose indicated on the partof the number sleeve of the injection device 1 in front of the camerachanges. When the injection process is complete, the user may press theconfirm or OK button 34 again or may allow the timer to timeout. Thesupplementary device 2 LCD display 21 then changes to display“Complete”. The supplementary device 2 at this time displays theremaining dosage in the injection device 1 on the LCD display 21. Theremaining dose typically is zero but it may be higher if the user didnot complete the injection.

Next, the mobile medicament administration monitoring application 110displays the administered dose on the mobile device display, and mayalso display the final dialled dose to allow the user to check that themobile device 100 has registered the correct final dialled dose. Themedicament administration monitoring application 110 on the mobiledevice 100 also displays a message indicating that a record relating tothe administered dosage has been created and stored.

Further, advantageously HDR images are captured by the image capturingdevice 25 in order to contribute to a high contrast of the dosageinformation so that binarization and OCR calculation in the mobiledevice 100 is improved.

The scope of the disclosure is not limited to the above-describedembodiments and various alternatives will be envisaged by the skilledperson. Further alternatives will now be described.

In FIG. 2b , the communications button 33 can be omitted from thesupplementary device. When the power button 22 is pressed, thesupplementary device 2 can turn on and automatically establishconnection with the mobile device 100. This simplifies the function ofthe supplementary device 2 and allows it to have fewer hardware buttons.

At step 608, the mobile device 100 may display both the dose dialledinto the injection device 1 after delivery and the calculated dose. Thiscan allow the user to check the dialled dose calculated by the mobiledevice 100 against the dose displayed on the LCD display 21 of thesupplementary device 2. The mobile device 100, through the medicamentadministration monitoring application 110, may allow the user to varythe dialled dose from that calculated by the optical characterrecognition process. This can allow the record of medicamentadministration recorded in the mobile device 100 to be more accuratethan otherwise.

Instead of transmitting image data only in response to a user input onthe supplementary device 2, operation may differ. For instance, imagedata may be transmitted continually or frequently to the mobile device100, and the mobile device may then display the dialled dose as diallingoccurs and/or as injecting occurs. In this case, the user inputindicating that the dose has been set may be made on the mobile device100 instead of on the supplementary device 2. In this case, the user cancheck the dialled dose indicated on the mobile device 100 (which hasbeen subjected to optical character recognition) against the imagedisplayed on the LCD display 21 of the supplementary device 2.Similarly, the user indicating that the injection has completed may bemade on the mobile device 100 instead of the supplemental device 2.Alternatively, both the supplemental device 2 and the mobile device 100may be configured to receive the dose set user input and/or theinjection complete user input, thereby allowing the user more choicesfor using the system.

The indication that the dose has been set may be made alternatively oradditionally on the mobile device. The same applies to the indicationthat the dose has been delivered. In the above, the image data is sentto the mobile device during the dose delivery process.

Alternatively, the image data may be stored in the memory 241 of thesupplementary device 2 and transmitted to the mobile device 100 at alater time, for instance minutes, hours or tens of hours later.Transmission to the mobile device may include images for two or moredose deliveries.

The supplemental device 2 may include a means for detecting themedicament included in the injection device 1. This may take the form ofa colour sensor that is configured to detect the colour of a label onthe injection pen, the label colour indicating the type of medicamentcontained.

1. A mobile device, comprising: a display; a processor; a wirelesscommunications interface; and a memory configured to store a medicamentadministration monitoring application, wherein the processor isconfigured to: execute the medicament administration monitoringapplication, establish, via the wireless communications interface, acommunications link between the mobile device and a supplementarydevice, wherein the supplementary device is releasably coupled to amedicament dispensing device configured to inject a dose of medicamentinto a patient through a needle, receive, from the supplementary device,dosage information associated with the dose of medicament injected intothe patient, and generate, via the medicament administration monitoringapplication, a record of medicament administration based on the dosageinformation.
 2. The mobile device according to claim 1, wherein theprocessor is configured to establish the communications linkautomatically or automatically in response to a signal that thesupplementary device has been powered on.
 3. The mobile device accordingto claim 1, wherein the processor is configured to establish thecommunications link in response to an input on the mobile device or inresponse to a signal from the supplementary device.
 4. The mobile deviceaccording to claim 1, wherein the processor is configured to execute themedicament administration monitoring application in response to a userinput applied to the mobile device.
 5. The mobile device according toclaim 1, wherein the processor is configured to execute the medicamentadministration monitoring application automatically when a signal isreceived from the supplementary device.
 6. The mobile device accordingto claim 1, wherein the wireless communications interface comprises awireless transceiver configured to establish a connection to thesupplementary device.
 7. The mobile device according to claim 1, whereinthe wireless communications interface is a Bluetooth interface orBluetooth Low Energy interface.
 8. The mobile device according to claim1, wherein the record of medicament administration comprises at leastone of time information, date information, and a type of medicament. 9.The mobile device according to claim 8, wherein the record of medicamentadministration comprises the type of medicament, wherein the type ofmedicament is based on a signal received by a color sensor configured todetect a color of the medicament dispensing device, and wherein thecolor of the medicament dispensing device is indicative of the type ofmedicament.
 10. The mobile device according to claim 8, wherein therecord of medicament administration comprises the type of medicament,wherein the type of medicament comprises insulin, and the dosageinformation comprises at least one of a dialed dose, an end dose, and adelivered dose.
 11. The mobile device according to claim 1, wherein theprocessor is configured to display the dosage information on thedisplay.
 12. The mobile device according to claim 1, wherein theprocessor is configured to cause the display to display the dosageinformation with an indication that a delivered dose is being displayed.13. The mobile device according to claim 1, wherein the processor isconfigured to cause the display to display an indication that the recordhas been created or stored, wherein the indication is in the form oftext or an image.
 14. The mobile device according to claim 1, whereinthe mobile device is configured to receive a user input indicating thata medicament delivery process is complete and is configured to controlthe display to display an indication that the medicament deliveryprocess is complete.
 15. The mobile device according to claim 1, whereinthe record of medicament administration is stored in the memory of themobile device.
 16. The mobile device according to claim 1, wherein themobile device comprises a smart phone or a tablet that comprises a touchscreen.
 17. A dose monitoring and recording system for insulinadministration, comprising: a supplementary device for attachment to aninsulin delivery device, wherein the supplementary device comprises afirst processor and a wireless communications unit, and thesupplementary device is configured to transmit data representing a doseof insulin administered by the insulin delivery device; and a mobiledevice for receiving and storing data received from the supplementarydevice, wherein the mobile device comprises a processor, a wirelesscommunications interface, a display, and a memory, wherein the mobiledeice is configured to: receive, via the wireless communicationsinterface, data transmitted from the wireless communications unit of thesupplementary device, display, on the display, an indication of the doseof insulin administered, and store, in the memory, a record of the doseof insulin based on the received data.
 18. The system of claim 17,wherein the supplementary device comprises a button configured to turnthe supplementary device on or off, and the button is located at aproximal end of the supplementary device.
 19. The system of claim 17,wherein the insulin delivery device has a distal end configured toreceive a needle.
 20. The system of claim 17, wherein the insulindelivery device comprises a dosage dial configured to turn to set thedose of insulin to be administered by the insulin delivery device, thedosage dial being located at a proximal end of the delivery device,wherein the supplementary device is configured for coupling to theproximal end of the delivery device.
 21. The system of claim 17, whereinthe mobile device is configured to store, in the memory, a dose diarycontaining a plurality of records tracking a plurality of doses ofinsulin based on the received data.
 22. A method for monitoring andrecording insulin administration, comprising: executing, by a processorof a mobile device of a monitoring system, a medicament administrationmonitoring application preloaded in a memory of the mobile device;detecting, by a processor of a supplementary device of the monitoringsystem, a depression of a button located at a proximal end of thesupplementary device to activate the supplementary device andestablishing a wireless communication link between a supplementarydevice of the monitoring system and the mobile device, wherein thesupplementary device is attached to a proximal end of an insulindelivery device, wherein the insulin delivery device has a distal endconfigured to receive a needle, capturing, by the supplementary device,data representative of a dialed dose of insulin of the insulin deliverydevice; transmitting, by the processor of the supplementary device, datarepresenting the dialed dose of insulin to the mobile device; andexecuting, by the processor of the mobile device, the medicamentadministration monitoring application to record the data representingthe dialed dose of insulin in the memory of the mobile device.
 23. Themethod of claim 22, wherein the wireless communication link usesBluetooth pairing.
 24. The method of claim 22, further comprisingdisplaying an indication of the dialed dose of insulin on a display ofthe mobile device.
 25. The method of claim 22, further comprisingdownloading the medicament administration monitoring application to themobile device from an application marketplace or an application store.26. The method of claim 22, further comprising capturing a time or adate of insulin injection using a clock of the mobile device.
 27. Themethod of claim 22, further comprising pre-processing data representingthe dialed dose of insulin by the processor of the supplementary device.28. The method of claim 27, further comprising additional processing ofdata representing the dialed dose of insulin by the processor of themobile device.
 29. The method of claim 22, further comprising recordinga plurality of data representing a plurality of dialed doses of insulinin the memory of the mobile device.
 30. A mobile device, comprising: adisplay; a processor; a wireless communications interface; and a memoryconfigured to store a medicament administration monitoring application,wherein the processor is configured to: execute the medicamentadministration monitoring application, establish, via the wirelesscommunications interface, a communications link between the mobiledevice and a supplementary device, wherein the supplementary device isreleasably coupled to a medicament dispensing device configured toinject a dose of medicament into a patient through a needle, receive,from the supplementary device, dosage information associated with thedose of medicament administered to the patient, and generate, via themedicament administration monitoring application, a record of medicamentadministration based on the dosage information, wherein the dosageinformation comprises a dialed dose and a final dose, wherein theprocessor is further configured to: if the final dose is zero, confirmthat the dialed dose is a delivered dose, and if the final dose isgreater than zero, determine the delivered dose by subtracting the finaldose from the dialed dose.